RotaTeq is a live, oral pentavalent vaccine that contains 5 live reassortant rotaviruses. The rotavirus parent strains of the reassortants were isolated from human and bovine hosts. Four reassortant rotaviruses express one of the outer capsid proteins (G1, G2, G3, or G4) from the human rotavirus parent strain and the attachment protein (type P7) from the bovine rotavirus parent strain. The fifth reassortant virus expresses the attachment protein, P1A (genotype P[8]), herein referred to as type P1A[8], from the human rotavirus parent strain and the outer capsid protein of type G6 from the bovine rotavirus parent strain.

The reassortants are propagated in Vero cells using standard cell culture techniques in the absence of antifungal agents.

In the manufacturing process for RotaTeq, a porcine-derived material is used. DNA from porcine circoviruses (PCV) 1 and 2 has been detected in RotaTeq. PCV-1 and PCV-2 are not known to cause disease in humans

RotaTeq is a pale yellow clear liquid that may have a pink tint.

The plastic dosing tube and cap do not contain latex.

INDICATIONS AND USAGE

RotaTeq is a vaccine indicated for the prevention of rotavirus gastroenteritis caused by types G1, G2, G3, G4, and G9. (1)

RotaTeq is approved for use in infants 6 weeks to 32 weeks of age. (1)

DOSAGE AND ADMINISTRATION

FOR ORAL USE ONLY. NOT FOR INJECTION. (2)

The vaccination series consists of three ready-to-use liquid doses of RotaTeq administered orally starting at 6 to 12 weeks of age, with the subsequent doses administered at 4- to 10-week intervals. The third dose should not be given after 32 weeks of age. (2)

No safety or efficacy data are available from clinical trials regarding the administration of RotaTeq to infants who are potentially immunocompromised (e.g., HIV/AIDS). (5.2)

In a post-marketing study, cases of intussusception were observed in temporal association within 21 days following the first dose of RotaTeq, with a clustering of cases in the first 7 days. (5.3, 6.2)

No safety or efficacy data are available for the administration of RotaTeq to infants with a history of gastrointestinal disorders (e.g., active acute gastrointestinal illness, chronic diarrhea, failure to thrive, history of congenital abdominal disorders, and abdominal surgery). (5.4)

Vaccine virus transmission from vaccine recipient to nonvaccinated contacts has been reported. Caution is advised when considering whether to administer RotaTeq to individuals with immunodeficient contacts. (5.5)